MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CL-5-M
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively in a open vaginal hysterectomy, the device¿s needle tip broke off and fell into the patient¿s cavity.An xray was performed with a negative result and the needle tip could not be located.The surgery was extended for thirty minutes and more due to the surgeon looking for the needle tip and for the x-ray.The patient was alive with no injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led a photographic evaluation of two devices.The visual inspection of the photograph noted zero sutures and two needles.One of the needles was observed to have a broken tip (addressed in pe# (b)(4)), but the other had no visual abnormalities.Unfortunately, because no sealed samples were returned, a bend moment test could not be performed.A review of the device history record indicates the product was released meeting all manufacturer's quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6837209
• Report Number: 9612501-2017-06070
• Device Sequence Number: 10774291
• Product Code: GAM
• UDI-Device Identifier: 10884521041462
• UDI-Public: 10884521041462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CL-5-M
• Device Catalogue Number: CL-5-M
• Device Lot Number: D6G2250X
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR